Product Profiles: Autism Spectrum Disorders -Underserved industry eagerly anticipates pipeline trial data

Publication date: June 2011

Keywords : Autism Spectrum Disorder

About This Report Over the past 6 years, three major events have impacted the autism spectrum disorders industry . In 2006, Risperdal became the first drug to receive approval from the US FDA for the symptomatic treatment of irritability in children and adolescents with ASDs. Later, in 2009, the FDA approval Abilify for the same indication. In 2008, generic risperidone launched following Risperdal’s US patent expiry. Wh...

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About This Report

Over the past 6 years, three major events have impacted the autism spectrum disorders industry . In 2006, Risperdal became the first drug to receive approval from the US FDA for the symptomatic treatment of irritability in children and adolescents with ASDs. Later, in 2009, the FDA approval Abilify for the same indication. In 2008, generic risperidone launched following Risperdal’s US patent expiry.

What's Included in This Report?

* Overview of industry ed and pipeline drugs in clinical development for autism spectrum disorders.

* Analysis of the industry positioning of each product approved for the treatment of autism spectrum disorders.

* Assessment of the strengths, weaknesses, opportunities and threats for industry ed and late-stage pipeline candidates.

* Summary of the clinical and commercial attractiveness for each of the industry ed products.

* Insight from key opinion leaders on industry ed and pipeline products.

Key Market Facts

Risperdal and Abilify are the only two products approved for the treatment of autism spectrum disorders (ASDs). Both of these atypical antipsychotics are indicated for the management of irritability symptoms associated with ASDs in the US. Due to the failure of these drugs to address the core symptoms of ASDs, many other drugs are used off-label.
Abilify is the most recent entrant to the ASDs industry, having received US Food and Drug Administration (FDA) approval in November 2009. The drug's partial agonism of dopamine receptors unique mechanism of action is considered a key differentiating factor, producing a superior side-effect profile compared to other atypical antipsychotics.
To date, none of the four late-stage pipeline candidates for autism spectrum disorders has publically presented the late-stage Phase II or III trial data necessary for the clinical assessment of these compounds.

Why Should You Buy This Report?

* What are the key differentiating features of approved therapies for the treatment of autism spectrum disorders?

* How do key opinion leaders perceive available treatments for autism spectrum disorders?

* What opportunities are there for existing players in the autism spectrum disorders industry to increase their industry share?

* What is the development status of current pipeline candidates development status?

* What clinical trial design are current pipeline canddiates following? What do pipeline candidates need to demonstrate in order to be successful?

Pathology Industry in the United States

Mental Illness in United States